Live and On-Demand Events

AgencyIQ attending DIA 2025 Global Annual Meeting

June 15, 2025 | INDUSTRY EVENT

Alexander Gaffney, Casey Miles, Joshua Sztorc, Rachel Gartlan, Laura DiAngelo, Amanda Conti

The AgencyIQ Team will be attending the DIA 2025 Global Annual Meeting, at the Walter E. Washington Convention Center in Washington, DC. The conference will be covering the most pressing topics in the life sciences field, discuss innovative solutions, and provide networking opportunities. The AgencyIQ Team will be attending sessions as well exhibiting at booth #1909.

FDA Regulatory Update: What the Trump administration’s regulatory (and deregulatory) agenda means for FDA policy

May 28, 2025 | 12:00 pm – 1:00 pm

Alexander Gaffney, Laura DiAngelo

Following months of upheaval during the transition to the Trump administration, the life sciences industry and the FDA are facing a different regulatory and policymaking landscape with new leadership, new directives from the White House and a new direction for regulators.

What do life sciences regulatory professionals need to know about what has happened – and what will happen next? Join AgencyIQ for this fast-paced, lively and actionable webinar where we’ll cover what has happened and what challenges are next for the FDA and the life sciences industry.

FDA Regulatory Update: What the destruction of the FDA as we know it means for medical product regulation

April 22, 2025 | AVAILABLE ON-DEMAND

Alexander Gaffney, Laura DiAngelo

The FDA has just endured one of the most turbulent periods in its history. Thousands of staff have been laid off. A new commissioner leads the agency. A major reorganization looms. New political pressures are being felt. Its user fee programs face potential collapse.

What do life sciences regulatory professionals need to know about what has happened – and what will happen next?

Join AgencyIQ for this fast-paced, lively and actionable webinar where we covered what has happened and what challenges are next for the FDA and the life sciences industry.

FDA Regulatory Update: How the Trump administration is affecting the FDA

March 25, 2025 | AVAILABLE ON-DEMAND

Alexander Gaffney, Laura DiAngelo

It has been two months since the start of the Trump administration, and deregulatory and downsizing efforts are starting to have effects on the FDA and the life sciences industry it regulates. Where do things go from here?

Join AgencyIQ’s regulatory experts for an informative, fast-paced, lively and actionable webinar focused on how the new Trump administration continues to affect health care product regulation.

We provided in-depth explanations of how FDA policies have been impacted so far, what we’re expecting to happen next, analysis of important staffing changes, and emerging trends and policies. We’ll also have a preview of what we expect from the FDA’s new commissioner, Marty Makary.

AgencyIQ’s regulatory policy and intelligence experts will also be on-hand to answer your questions live.

U.S. and EU Chemicals Regulatory Update: A Road of Twists and Unknowns

March 4, 2025 | AVAILABLE ON-DEMAND

Scott Stephens, Julia John, Xiaolu Wang

As expected, chemicals policy has taken a turn in 2025 under Donald Trump’s administration in the U.S. and Ursula von der Leyen’s new commission in the EU.

Join AgencyIQ by POLITICO regulatory analysts, Xiaolu Wang and Scott Stephens, and editor, Julia John, for an informative discussion about where chemical regulations may be headed on both sides of the Atlantic based on what we’ve seen in the first months of the year. Tune in to learn more about how companies can prepare to face the uncertainties ahead.

U.S. topics include executive orders relevant to chemicals policy, congressional and legal challenges to Biden-era chemical rules, and developments in state-level chemical regulations in major jurisdictions like California. For the EU, we examine the status of the Commission’s long-awaited proposal to revise REACH, as well as ECHA’s work to fulfill its new obligations under the recent CLP revision and Packaging and Packaging Waste Regulation (PPWR).

FDA Regulatory Update: How the Trump Administration’s policies are affecting the FDA

February 25, 2025 | AVAILABLE ON-DEMAND

Alexander Gaffney, Laura DiAngelo

The regulatory environment is in the midst of a period of transformative change, with major restrictions on regulation, staff changes, budget cuts and other developments that are set to have extraordinary impacts on the FDA’s regulation of the life sciences sector.

AgencyIQ by POLITICO is keeping close track of these fast-moving changes and developments. During this webinar we provided in-depth explanations of how FDA policies have been impacted so far, what we’re expecting to happen next, analysis of important staffing changes, and emerging trends and policies.

FDA Regulatory Update: Unpacking FDA’s new policies and the early days of the Trump administration

January 28, 2025 | AVAILABLE ON-DEMAND

Alexander Gaffney, Laura DiAngelo

The FDA is off to a fast start to 2025, with a blizzard of new guidance, new policies, and major staffing changes that will have significant impacts for regulated industry in 2025.

This lively, fast paced webinar will provide in-depth explanations of key FDA guidance documents, analysis of important staffing changes, and updates on new policies emerging from the administration of President Donald Trump. AgencyIQ’s regulatory policy and intelligence experts will also be on-hand to answer your questions live.

A 2025 Regulatory Forecast for the U.S. and E.U. Chemical Sectors

December 18, 2024 | AVAILABLE ON-DEMAND

Scott Stephens, Julia John, Xiaolu Wang

A second Trump administration and the European Commission’s new mandate herald potentially momentous shifts in chemicals policy.

As we enter the final stretch of 2024, join regulatory analysts Xiaolu Wang and Scott Stephens, along with chemicals editor Julia John, for a lively discussion about the future of chemical regulations on both sides of the Atlantic.

U.S. topics include TSCA developments, PFAS activities, and the potential impacts of the imminent Trump presidency. For the E.U., we examined the incoming Commission’s regulatory priorities and the challenges facing the European Chemicals Agency (ECHA) as its purview expands to include additional regulations, such as the Batteries Regulation and the Drinking Water Directive.

FDA Forecast: What’s next in 2025

December 10, 2024 | AVAILABLE ON-DEMAND

Alexander Gaffney, Laura DiAngelo

What will the FDA do in 2025, and how could the incoming Trump administration radically alter the agency’s plans? In this timely, lively and informative event, regulatory experts from POLITICO’s AgencyIQ will explain what regulatory professionals should anticipate in the year ahead based on emerging trends, political updates, known issues, regulations, guidance documents and more.

What the 2024 Election Means for FDA and the Industries it Regulates

November 13, 2024 | AVAILABLE ON-DEMAND

Alexander Gaffney, Laura DiAngelo

From the White House to White Oak, the 2024 Presidential and Congressional elections will have significant impacts on the FDA, its policy agenda and its approach to regulation.

After the election, join AgencyIQ for an in-depth, lively, and detailed expert discussion focused on how the election will affect both the FDA and the industries it regulates. Attendees will benefit from actionable insights they can use to plan ahead.

AgencyIQ by POLITICO is a RAPS RAC Approved Provider. This education program meets the RAPS RAC recertification requirements to maintain the RAC credential. For more information about the RAC credential or the Approved Provider program, please visit www.raps.org.

Guidance Roundup: FDA’s end-of-year push on clinical trial policy

October 22, 2024 | AVAILABLE ON-DEMAND

Alexander Gaffney, Laura DiAngelo

In closing out the federal fiscal year, the FDA has released a bevy of new guidance documents related to clinical trials. Altogether, the documents provide a look into how the FDA – and industry – are grappling with new research methods and technologies, and how regulators see interpretation of the existing regulatory paradigms into these new contexts.

At this webinar, AgencyIQ walked through the new documents, focusing on the intersection of the policies with other high-priority developments out of FDA – including real-world data (RWD), digital health technologies (DHTs), new trial designs, and the agency’s work on Diversity Action Plans (DAPs).

AgencyIQ attending RAPS Convergence 2024

September 17, 2024 | INDUSTRY EVENT

Alexander Gaffney, Corey Jaseph, Amanda Conti, Joshua Sztorc, Rachel Gartlan

The AgencyIQ Team will be attending RAPS Convergence 2024, at Long Beach Convention & Entertainment Center, in Long Beach, CA. The annual event, hosted by Regulatory Affairs Professionals Society (RAPS), is the largest gathering of global regulatory affairs professionals. The AgencyIQ Team will be attending sessions as well exhibiting at booth #708.

RAPS Convergence is the largest and most recognized annual gathering of global regulatory affairs professionals. Convergence brings together representatives of industry, regulatory bodies, research, academia, and clinical organizations that are directly involved in managing the regulatory process and aligning science, regulation, and business strategy.

FDA Forecast: What the FDA has Left to Do in its Sprint to the End of 2024

August 27, 2024 | AVAILABLE ON-DEMAND

Alexander Gaffney, Laura DiAngelo

The FDA has been incredibly busy throughout 2024, with the release of several major regulations and guidance documents. But as busy as the agency has been, there’s still much that it has planned between now and the end of the calendar year.

Join AgencyIQ’s research team for a fast-paced, lively, in-depth and informative webinar looking at the guidance, regulations, projects, commitments, and political pressures that the FDA still has on its plate in 2024, and what it means for the life sciences industry.

A Deep Dive into FDA’s new Diversity Action Plan Draft Guidance

July 30, 2024 | AVAILABLE ON-DEMAND

Alexander Gaffney, Laura DiAngelo, Rachel Coe, Amanda Conti

In late June, FDA published a long-awaited and highly anticipated draft guidance document on Diversity Action Plans. Once finalized, the document will have sweeping impacts on sponsors of pharmaceutical, biopharmaceutical, and medical device products, and companies have a short window of time to make suggestions to the FDA on what improvements to make.

Join AgencyIQ’s research team for a fast-paced, lively, in-depth and informative webinar looking at the guidance, how it would affect the life sciences industry, areas where industry is likely to request changes, potential implementation challenges, and more. We will also be available to answer questions about the guidance during the webinar.

EU Chemical Priorities in the Second Half of 2024 and Beyond

July 16, 2024 | AVAILABLE ON-DEMAND

Scott Stephens, Alexander Gaffney

As the incoming Commission slowly takes shape post-elections, Europe’s chemical regulators have remained busy formulating their priorities for the next year and beyond.

Join AgencyIQ’s regulatory experts, Scott Stephens and Alexander Gaffney, for a deep dive into the plans ECHA and the Commission services are considering, including follow-up actions to the Integrated Regulatory Strategy (IRS) and Joint Evaluation Action Plan (JEAP), related enforcement initiatives, and more.

What the 2024 Election Means for the FDA

June 25, 2024 | AVAILABLE ON-DEMAND

Alec Gaffney, Laura DiAngelo

The 2024 Presidential Election is just five months away, and its outcome is likely to have significant impacts on the Food and Drug Administration and its regulation of medical products.

In this fast-paced, informative and lively webinar, AgencyIQ’s regulatory experts will present an objective viewpoint into how the results of the Presidential and Congressional elections could have wide-ranging effects on FDA’s authority, regulatory agenda, and oversight. We’ll also provide analysis of which things are likely to stay the same, which actions have bipartisan support, and provide insights into how FDA typically fares in an election year.

Halfway Through 2024: EPA Regulation at a Crossroads

June 11, 2024 | AVAILABLE ON-DEMAND

Walker Livingston, Alexander Gaffney

The EPA has been busy, issuing a wide range of important regulations in the first half of the year. In this AgencyIQ deep dive, Walker Livingston and Alexander Gaffney will explain what the agency has done so far this year and what it plans to do in the lead-up to the election and potential changeover in presidential administration.

FDA’s Laboratory Developed Test (LDT) Final Rule: What it Means for Regulated Industry

May 22, 2024 | AVAILABLE ON-DEMAND

Alexander Gaffney, Laura DiAngelo

The FDA recently finalized its long-expected rule to re-configure regulatory oversight for laboratory developed tests (LDTs), setting off a torrent of work for the agency (and industry) and raising significant questions about what implementation of the final rule will look like.

In this fast paced, informative webinar, AgencyIQ will provide a deep-dive on the rule itself, as well as key takeaways not just for LDT stakeholders, but the potential anticipated impacts on the diagnostics, medical devices, pharmaceutical and biopharmaceutical sectors.

AgencyIQ attending RAPS Regulatory Intelligence Conference

June 6, 2024 | INDUSTRY EVENT

Alexander Gaffney, Laura DiAngelo

The AgencyIQ Team will be attending RAPS Regulatory Intelligence Conference, at Hilton Baltimore BWI Airport, in Baltimore, MD. This conference will explore key regulatory affairs topics in a collaborative and engaging environment.

What’s Next for Chemicals Policy After the EU Parliamentary Elections?

May 14, 2024 | AVAILABLE ON-DEMAND

Scott Stephens, Rayan Bhargava, Alexander Gaffney

The current direction of EU chemicals policy hangs in the balance as European citizens prepare to cast their ballots in the upcoming EU-wide parliamentary elections this June. Their outcome will determine the composition of the new Commission and, consequently, shape the agenda for regulating chemicals for the next five years.

Join AgencyIQ’s chemicals regulatory experts, Scott Stephens and Rayan Bhargava, for a lively discussion of the main drivers of EU chemicals regulation in the second half of this year, including the ongoing universal PFAS restriction proposal, the Commission’s exploration of substitution planning, and its newly unveiled communication on the essential use concept.

Halfway Through FFY2024: What’s Left on FDA’s List?

April 23, 2024 | AVAILABLE ON-DEMAND

Alexander Gaffney, MS, RAC, Laura DiAngelo, MPH

Halfway through federal fiscal year 2024, the FDA has released myriad new guidance, policies and regulations with significant impact on the life sciences industry – while still more policies are outstanding in the second half of this fiscal year.

In this fast-paced, lively and informative webinar, AgencyIQ’s regulatory experts will provide in-depth analyses of what’s coming next in regulated medical product policy, covering issues related to related to pharmaceuticals, biopharmaceuticals, medical devices, digital health technologies and diagnostics.

The webinar will focus on what to-do’s remain on FDA’s list as it heads into the back end of federal fiscal year 2024, including new (and outstanding) guidance documents, user fee commitments, and regulations – as well as updates on Congressional activity that could impact the agency and regulated industry.

The State of TSCA: A comprehensive deep dive

April 17, 2024 | AVAILABLE ON-DEMAND

Walker Livingston, Alexander Gaffney

This engaging and informative webinar will delve deep into the EPA’s administration of the Toxic Substances Control Act (TSCA) and look ahead to what we can expect for the future. AgencyIQ’s chemicals regulatory experts will thoroughly explain the status of current risk assessments and management actions, as well as detail the agency’s plans for future rules and procedures.

European Life Sciences Regulatory Review: Q1 2024

March 26, 2024 | AVAILABLE ON-DEMAND

Alexander Gaffney, Corey Jaseph, Kirsten Messmer

European regulators, including the EMA, MHRA and Swissmedic, have been busy in the first quarter of 2024. Already, the life sciences industry has new regulations, guidelines, policies and even legislation to contend with, including new developments related to the MDR and IVDR, efforts to transform MHRA’s regulatory frameworks, and pending efforts to launch a new pharmaceutical regulatory system.

Join AgencyIQ’s regulatory experts for a fast-paced, lively and informative webinar covering the latest European regulatory issues related to related to pharmaceuticals, biopharmaceuticals, medical devices, digital health technologies and diagnostics.